83136 Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 

required to notify FDA, when such 

notifications are required, what 

information FDA expects manufacturers 

to include in such notifications, and 

how to submit notifications. 

Additionally, FDA describes how FDA 

determines that a device is in shortage 

and additional actions FDA may take to 

help prevent or mitigate a potential 

device shortage. 

In the draft guidance ‘‘Select Updates 

for the 506J Guidance: 506J Device List 

and Additional Notifications,’’ FDA 

proposes updates to the 506J Guidance. 

Specifically, FDA has developed a list of 

devices, by FDA product code, for 

which a manufacturer of such devices is 

required to notify FDA in accordance 

with section 506J (hereafter referred to 

as the ‘‘506J Device List’’). The 506J 

Device List is based on the requirements 

under section 506J(a) of the FD&C Act. 

In section 2514 of the FY 2023 

Omnibus, Congress directed FDA to 

issue guidance on the requirements 

under section 506J and to include ‘‘a list 

of each device product code for which 

a manufacturer of such device is 

required to notify the Secretary in 

accordance with section 506J.’’ Thus, 

manufacturers of a device on the 506J 

Device List must notify FDA in 

accordance with 506J for each such 

device. For more information, 

manufacturers should see the 506J 

Device List web page, available at 

https://www.fda.gov/medical-devices/ 

medical-device-supply-chain-andshortages/506j-device-list. Additionally, 

consistent with section 506J(h), FDA is 

proposing to clarify for stakeholders that 

manufacturers may submit, and FDA 

may receive, voluntary notifications 

regarding supply chain issues at any 

time, unrelated to the declaration or 

potential declaration of a PHE. 

The guidance documents include 

additional voluntary items that 

manufacturers could provide the 

Agency, including additional 

information about device manufacturing 

and supply, and updates to initial 

notifications. 

Respondents may notify FDA about 

an interruption or permanent 

discontinuance in device manufacturing 

(506J notification) on our website at 

https://fda-cdrh.my.salesforcesites.com/shortages/. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average burden per 

response 

(hours) 

Total hours 

Shortages outreach data collection ............................................................. 1,000 4 4,000 1 .................................. 4,000 

Information collection under section 506J ................................................... 8,400 1 8,400 0.25 (15 minutes) ....... 2,100 

Additional voluntary collections related to section 506J .............................. 8,400 1 8,400 0.25 (15 minutes) ....... 2,100 

Total ...................................................................................................... ........................ ........................ 20,800 ..................................... 8,200 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

I. Shortages Outreach Data Collection 

FDA bases these estimates on our 

recent experience and informal direct 

contact with respondents. We estimate 

up to 1,000 manufacturers, distributors, 

healthcare systems, healthcare 

providers, group purchasing 

organizations, and sterilizers for which 

there may be targeted outreach because 

their devices may be essential to the 

response effort. This targeted outreach 

will be conducted periodically either to 

obtain primary data or to verify/validate 

updated data (although additional 

outreach may be undertaken as needed). 

The data being requested represent 

common data elements that respondents 

monitor and track as part of routine 

business operations and, therefore, are 

readily available. It is anticipated that 

for most respondents, the estimated 

time to fulfill CDRH’s data request will 

not exceed 1 hour per request, or 4 

hours per year. 

II. Information Collection Under 

Section 506J of the FD&C Act and 

Related Voluntary Collections 

Based on current registration and 

listing data (approved under OMB 

control number 0910–0625), we 

estimate the number of respondents that 

will submit a notification under section 

506J of the FD&C Act to be 

approximately 20 percent of currently 

registered manufacturers. Data from our 

Registration and Listing system indicate 

that there are approximately 42,000 

unique FDA Establishment 

Identification registered manufacturers. 

Therefore, we estimate 8,400 

respondents per year. We believe that 

the burden, including the provision of 

required information under section 506J 

of the FD&C Act, as well as additional 

voluntary information (including 

additional issues that may impact the 

availability of the device, such as 

information about critical suppliers, 

potential mitigations, production 

capacity and market share, and 

notification updates), is minimal and 

such information is readily available to 

respondents. Therefore, we estimate the 

burden of this information collection to 

be 15 minutes or less per notification. 

Since the last OMB approval, we have 

updated the Number of Respondents 

and Average Burden per Response for 

the Shortages Outreach Data Collection 

element based on our recent experience 

with the information collection and 

informal direct contact with 

respondents. The updates result in an 

adjustment of an additional 3,000 hours 

and 2,000 responses annually. 

Dated: November 22, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26199 Filed 11–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–2101] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Korsuva 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Korsuva and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 83137 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by January 29, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

May 28, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–E–2101 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; KORSUVA.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with § 10.20 (21 

CFR 10.20) and other applicable 

disclosure law. For more information 

about FDA’s posting of comments to 

public dockets, see 80 FR 56469, 

September 18, 2015, or access the 

information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, Korsuva 

(difelikefalin acetate). Korsuva is 

indicated for the treatment of moderateto-severe pruritus associated with 

chronic kidney disease in adults 

undergoing hemodialysis. Subsequent to 

this approval, the USPTO received a 

patent term restoration application for 

Korsuva (U.S. Patent No. 7,402,564) 

from Cara Therapeutics, Inc., and the 

USPTO requested FDA’s assistance in 

determining the patent’s eligibility for 

patent term restoration. In a letter dated 

September 28, 2022, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of Korsuva 

represented the first permitted 


lotter on DSK11XQN23PROD with NOTICES1
83138 Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

Korsuva is 4,625 days. Of this time, 

4,381 days occurred during the testing 

phase of the regulatory review period, 

while 244 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: December 26, 

2008. The applicant claims January 16, 

2009, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was December 26, 

2008, which was 30 days after FDA 

receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 23, 2020. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

Korsuva (NDA 214916) was initially 

submitted on December 23, 2020. 

3. The date the application was 

approved: August 23, 2021. FDA has 

verified the applicant’s claim that NDA 

214916 was approved on August 23, 

2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,827 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: November 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26106 Filed 11–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–2188 and FDA– 

2022–E–2189] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Tavneos 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Tavneos and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of 

patents which claim that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by January 29, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

May 28, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2022–E–2188 and FDA–2022–E–2189 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; TAVNEOS.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 


lotter on DSK11XQN23PROD with NOTICES1